510(k) · Cleared
ClearedMeca Xpressfish
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advandx, Inc. · MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Cleared on Oct 10, 2014 as substantially equivalent to K090301 (Binax, Inc., 2010) after a 213-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Oct 10, 2014
- Review
- 213 days
- Class
- Class II
- Product code
- MYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K850291 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K850291 | Mueller Hinton Agar W/4% Nacl W/Antibiotics | Remel Co. | 1985 | 2 |
| −1 | K090301 | Binaxnow PBP2A Test, Model 890-000 | Binax, Inc. | 2010 | — |
| 0 (this device) | K140619 | Meca Xpressfish | Advandx, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090301 | Binaxnow PBP2A Test, Model 890-000Summary page 5…ication of mecA-mediated methicillin (Oxacillin) resistance in S. aureus, the mecA XpressFISH assay is substantially equivalent to the BinaxNOW PBP2a test (Alere, Maine, k090301), which detects the PBP2a protein responsible for methicillin resistance. Comparison Tables of Simila… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 24.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MYI devicesMYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MYI
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · MYI
Too few MYI 510(k)s in any year since 2007 to give a median.
Recalls per year · MYI
No recall names MYI since 2007.
Adverse event reports per year · MYI
2in 2023
MAUDE reports naming product code MYI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay. The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus…
Read the full statement (125 words)
mecA XpressFISH® is a qualitative nucleic acid fluorescence in situ hybridization assay intended for the detection of mecA mRNA on smears from blood cultures that are positive for Staphylococcus aureus by the Staphylococcus QuickFISH™ BC assay.
The mecA XpressFISH® assay is indicated for use in conjunction with other laboratory tests and clinical data available to the clinician as an aid in the detection of mecA mRNA from methicillin-resistant S. aureus (MRSA) from patient positive blood cultures. The mecA XpressFISH® assay is not intended to monitor treatment for MRSA infections or for use with mixed cultures including those containing both S. aureus and coagulase negative staphylococci.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, epidemiological typing, and/or differentiation of mixed growth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140619: Meca Xpressfish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140619
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026